MedMatrix Rx
Daily 340B Morning Briefing
Novartis Pharmaceuticals has filed an appeal in the Eighth Circuit against Missouri’s Attorney General, challenging state-level 340B program restrictions. Johnson & Johnson mandates 340B entities to submit claims data to maintain pricing, affecting compliance and operations. ASHP advocates for expanded Medicare coverage and 340B protections. Multiple lawsuits involving major pharmaceutical companies and health systems continue to shape the 340B legal landscape.
EXECUTIVE SUMMARY
01
Novartis appeals Missouri 340B restrictions.
Novartis Pharmaceuticals filed an appeal in the Eighth Circuit against Missouri’s Attorney General, challenging 340B program restrictions.
Novartis Pharmaceuticals filed an appeal in the Eighth Circuit against Missouri’s Attorney General, challenging 340B program restrictions.
Source: CourtListener — 340B Search
02
J&J requires 340B claims data submission.
Johnson & Johnson mandates 340B covered entities to submit claims data for outpatient drugs to maintain 340B pricing.
Johnson & Johnson mandates 340B covered entities to submit claims data for outpatient drugs to maintain 340B pricing.
Source: beckershospitalreview.com
03
ASHP pushes for 340B protections on Capitol Hill.
ASHP advocates for expanded Medicare coverage and 340B Drug Pricing Program protections during meetings with congressional offices.
ASHP advocates for expanded Medicare coverage and 340B Drug Pricing Program protections during meetings with congressional offices.
Source: beckershospitalreview.com
04
CMS faces pressure over 340B payment cuts.
Healthcare groups urge CMS to reconsider proposed 340B payment cuts in the 2027 Outpatient Prospective Payment System rule.
Healthcare groups urge CMS to reconsider proposed 340B payment cuts in the 2027 Outpatient Prospective Payment System rule.
Source: beckershospitalreview.com
05
Froedtert Hospital sues CVS over 340B diversion.
Froedtert Memorial Lutheran Hospital filed a lawsuit against CVS Health alleging $18 million in 340B drug pricing savings diversion.
Froedtert Memorial Lutheran Hospital filed a lawsuit against CVS Health alleging $18 million in 340B drug pricing savings diversion.
Source: beckershospitalreview.com
06
AbbVie litigation continues in New Mexico.
AbbVie Inc. is engaged in ongoing litigation against Raul Torrez in the District of New Mexico regarding 340B program issues.
AbbVie Inc. is engaged in ongoing litigation against Raul Torrez in the District of New Mexico regarding 340B program issues.
Source: CourtListener — 340B Search
07
Massachusetts challenges federal policies in court.
The Commonwealth of Massachusetts is challenging federal policies in a lawsuit against former President Trump in District Court.
The Commonwealth of Massachusetts is challenging federal policies in a lawsuit against former President Trump in District Court.
Source: CourtListener — 340B Search
08
AHA opposes CMS 340B payment clawback proposal.
The American Hospital Association argues against CMS’s proposed increase in repayment rates for 340B overpayments in a letter to CMS.
The American Hospital Association argues against CMS’s proposed increase in repayment rates for 340B overpayments in a letter to CMS.
Source: beckershospitalreview.com
09
NASP comments on CMS 340B payment changes.
NASP submitted comments on CMS’s proposed changes to 340B payment methodology, focusing on reimbursement and compliance issues.
NASP submitted comments on CMS’s proposed changes to 340B payment methodology, focusing on reimbursement and compliance issues.
10
Mount Sinai sues CVS over 340B issues.
Mount Sinai Hospital filed a lawsuit against CVS Health in the Southern District of New York over 340B program disputes.
Mount Sinai Hospital filed a lawsuit against CVS Health in the Southern District of New York over 340B program disputes.
Source: CourtListener — 340B Search
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The ongoing legal battles and policy changes surrounding the 340B program illustrate the complex and contentious nature of drug pricing and healthcare reimbursement in the U.S. These developments could significantly impact hospital and pharmacy operations, particularly in terms of compliance and financial planning. As manufacturers like Johnson & Johnson impose stricter data submission requirements, covered entities must adapt to maintain access to 340B pricing. Meanwhile, advocacy efforts by organizations like ASHP highlight the ongoing debate over the role of pharmacists in healthcare delivery and the need for legislative support to protect and expand 340B program benefits.
Emerging risks.
- Failure to comply with J&J’s data submission requirements could result in loss of 340B pricing for covered entities.
- CMS’s proposed 340B payment cuts could financially strain hospitals, especially those heavily reliant on 340B savings.
- Ongoing litigation may lead to changes in 340B program rules, affecting contract pharmacy arrangements and reimbursement models.
- Legal challenges against state and federal policies could create uncertainty and operational disruptions for healthcare providers.
Emerging opportunities.
- Advocacy efforts by ASHP and other organizations could lead to expanded Medicare coverage for pharmacist services.
- Hospitals can engage in policy discussions to influence CMS’s final decisions on 340B payment rules.
- Covered entities can use legal outcomes to negotiate better terms with drug manufacturers and PBMs.
- Healthcare providers can use litigation outcomes to strengthen compliance frameworks and mitigate future risks.
Key actions for providers.
- Review and update compliance processes to meet J&J’s claims data submission requirements.
- Participate in advocacy efforts to support favorable 340B program policies and reimbursement models.
- Monitor ongoing litigation and policy changes to anticipate and adapt to potential impacts on operations.
- Engage with legal and policy experts to understand implications of court rulings on 340B program participation.
TOP STORIES
Novartis challenges Missouri’s 340B restrictions in Eighth Circuit.
CourtListener — 340B Search · September 16, 2026
- Novartis Pharmaceuticals filed an appeal in the Eighth Circuit against Missouri’s Attorney General.
- The case challenges state-level restrictions on the 340B Drug Pricing Program.
J&J mandates claims data for 340B pricing.
beckershospitalreview.com · September 11, 2026
- Johnson & Johnson requires 340B covered entities to submit claims data starting September 15.
- Non-compliance will lead to pricing suspension, with restoration upon data submission.
ASHP advocates for 340B protections and Medicare coverage.
beckershospitalreview.com · September 16, 2026
- ASHP members met with congressional offices to advocate for 340B protections.
- They seek expanded Medicare coverage for pharmacist-provided care.
FEDERAL POLICY & REGULATORY DEVELOPMENTS
CMS faces opposition over 340B payment cuts.
beckershospitalreview.com · August 31, 2026
- Healthcare groups submitted comments opposing CMS’s proposed 340B payment cuts.
- The proposed rule would increase repayment rates for prior 340B overpayments.
AHA opposes CMS’s repayment rate increase.
beckershospitalreview.com · August 26, 2026
- AHA urged CMS not to finalize a proposed increase in 340B repayment rates.
- The proposal would raise the rate from 0.5% to 3%, affecting hospital finances.
NASP comments on CMS’s 340B payment changes.
NASP — National Association of Specialty Pharmacy · September 1, 2026
- NASP submitted comments on CMS’s proposed changes to 340B payment methodology.
- The comments address reimbursement, compliance, and operational considerations.
340B PROGRAM DEVELOPMENTS
J&J imposes claims data requirement for 340B discounts.
Healthcare Dive · September 14, 2026
- Johnson & Johnson requires claims data submission to prevent duplicative discounts.
- The policy applies to all covered entity types and affects compliance processes.
STATE DEVELOPMENTS
New York — Court Ruling Upholds 340B Contract Pharmacy Restrictions
New York State Supreme Court · August 25, 2026
- New York State Supreme Court ruled on August 25, 2026, upholding the legality of restrictions imposed by drug manufacturers on 340B contract pharmacies.
- The court found that manufacturers have the right to limit the distribution of 340B drugs to contract pharmacies.
- Covered entities must comply with these restrictions to continue receiving 340B discounts.
- The ruling may impact the operations of covered entities relying on contract pharmacies for drug distribution.
LITIGATION & ENFORCEMENT WATCH
| Court | Matter | Date |
|---|---|---|
| 8th Cir. | Novartis Pharmaceuticals Corp. v. Catherine L. Hanaway, No. 25-1619, appeal filed. [source] | 2026-09-16 |
| D.D.C. | COREWELL HEALTH WILLIAM BEAUMONT UNIVERSITY HOSPITAL v. KENNEDY [source] | 2026-09-03 |
| E.D. Wis. | Froedtert Memorial Lutheran Hospital Inc v. CVS Health Corporation [source] | 2026-08-20 |
| D. Maryland | State of New York v. U.S. Department of Health and Human Services [source] | 2026-08-27 |
MANUFACTURER WATCH
| Manufacturer | Action | Date |
|---|---|---|
| Johnson & Johnson | Requires 340B covered entities to submit claims data for outpatient drugs. [source] | 2026-09-11 |
SOCIAL MEDIA & STAKEHOLDER SENTIMENT
The following items were identified through a web search for recent stakeholder and social commentary on the U.S. 340B Drug Pricing Program from the past 90 days, including reactions, statements, op-eds, and advocacy positions from hospital and health-center groups, provider and patient advocates, drug manufacturers, PBMs, and policy commentators.
AHA Feedback Re: the 340B for Patients Act Discussion Draft
American Hospital Association (AHA) · August 25, 2026
- Main theme: AHA’s opposition to proposed changes in the 340B program’s structure and implementation.
- Stakeholder sentiment: The AHA expresses concern over proposed changes, stating that the draft would create “enormous administrative burdens” and “fundamentally change the structure of the 340B program.”
- Potential implications: Potential administrative challenges and operational disruptions for hospitals, particularly rural and safety-net providers.
- Credibility: The AHA is a reputable organization representing hospitals and health systems across the U.S.
WHAT TO WATCH NEXT
- Monitor the outcome of Novartis’s appeal in the Eighth Circuit against Missouri’s 340B restrictions. [source]
- Track CMS’s response to stakeholder comments on the 2027 Outpatient Prospective Payment System proposed rule. [source]
- Watch for compliance challenges as Johnson & Johnson’s claims data submission requirement takes effect. [source]
- Follow ASHP’s advocacy efforts for expanded Medicare coverage and 340B protections in Congress. [source]
End of briefing.
This briefing is provided for informational purposes only and does not constitute legal, regulatory, financial, or compliance advice. Automated summarization may contain errors or omissions, and source materials may change after publication. Recipients should independently verify all information against the cited primary sources before relying on it.
© 2026 MedMatrix Rx. All rights reserved.